This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.

Phase IIb Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Tenofovir+Emtricitabine+Raltegravir or to Lamivudine+Abacavir+Raltegravir in Patients With Optimal Virological Control and Toxicity to the Current Combined Antiretroviral Regimen

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

To verify the persistent control of the virus replication after the simplification to tenofovir+emtricitabine+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any previous virological failure [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Patients switching to raltegravir with tenofovir+emtricitabine as backbone

Drug: tenofovir emtricitabine raltegravir

switch from current antiretroviral regimen to raltegravir with tenofovir/emtricitabine as backbone

Experimental: Lamivudine Abacavir Raltegravir

Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone

Drug: Lamivudine Abacavir Raltegravir

Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone

Experimental: Abacavir free

Patients switched to raltegravir whose backbone therapy should not be randomized in order to avoid the use of abacavir (HLA-B*5701 positive patients,Framingham score 20% or higher)

Drug: Abacavir free

Patients will receive raltegravir with tenofovir/emtricitabine; data will be added to those of Tenofovir Emtricitabine Raltegravir arm in a separate longitudinal analysis comparing data at baseline and at 48 weeks. In this separate analysis, data will not be compared to those obtained from the Lamivudine Abacavir Raltegravir arm. The number of patients in this arm is not pre-established.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients treated with a combined antiretroviral therapy from at least 1 year

Spontaneous treatment interruptions in disagreement with the treating physician in the last year or loss to follow-up for at least 6 months, at least once in the last two years

Current alcohol or drug abuse or any other condition which, in the judgment of the treating physician, may impair the patient's adherence to the new drug regimen and/or to the protocol's procedures

Patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid and glucose levels)

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958100